- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03046667
Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health (NEWDRINK)
The project is a randomized, 2-way, blinded parallel trial in which 56 healthy adults of both genders with frequent occurrence of stomach trouble.This intervention trial with 6 weeks of daily intake β-glucans will be carried out with a beverage containing β-glucans and a control beverage without β-glucans. The primary aim is to investigate whether β-glucans from barley has an effect on stomach and intestinal health, including stool volume and frequency. Microbiota, concentrations of short chain fatty acids (butyrate, propionate, acetate), calprotectin, and energy and fat content in feces. Furthermore, blood pressure and exhaled hydrogen and methane, before and after the intervention, subjective perception of gastrointestinal problems and digestion as well as the participants' attitudes towards functional foods are measured using Visual Analog Scale (VAS).
Further, specific metabolites of β-glucans in urine (exploratory endpoint) and certain toxic metabolites from the microbiota using metabolite profiling (metabolomics) are also analyzed
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Frederiksberg, Denmark, 1958
- Department of Nutrition, Exercise and Sports, University of Copenhagen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI 20 - 27 kg/m2
- Like test and control drink, pasta, meat sauce as these foods are part of the test meal.
- Healthy subjects sometimes or often bothered by mild gastric problems such as bloating, loose stools or constipation
- Willing to handle in 2 x 3-day total feces at the start and end of the study
Exclusion Criteria:
- Suffering from irritable bowel syndrome (IBS), bacterial overgrowth in the small intestine (SIBO) or inflammatory bowel disease (IBD).
- Systemic infections, psychiatric or metabolic diseases, and any clinical condition
- Chronic or frequent use of medication (including blood thinners, excluding contraceptives)
- Frequent loose stools
- Blood donations during or in the month leading up to the study period
- Elite athletes (> 10 hours of hard exercise / week, self-reported)
- High intake of alcohol (defined as a weekly intake of > 7 units for women and > 14 units for men),
- Have or have had a drug addiction
- Participation in other scientific studies during the study period
- Lactating
- Pregnancy or ongoing planning of pregnancy
- Vegetarianism or veganism.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test drink
Test drink: Barley β-glucan
|
The test beverages with Barley β-glucan is consumed by the participants for the first time at the trial site, followed by a 1 week running-in period were the participants was ingesting half a dose of test drinks.
Subsequent were a full dose of the test drinks consumed for 5 weeks.
In total was the test drinks consumed for 6 weeks.
Other Names:
|
Placebo Comparator: Control drink
Control drink: barley beverage
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The control beverages is consumed by the participants for the first time at the trial site, followed by a 1 week running-in period were the participants was ingesting half a dose of test drinks.
Subsequent were a full dose of the test drinks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stool volume
Time Frame: 0 and 6 weeks
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Changes in total stool weight 2 x 3 days from 72 hours before study start and 72 hours before study termination after 6 weeks, determined by a mixed model analysis.
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0 and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hydrogen
Time Frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
|
Changes in exhaled hydrogen concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate.
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0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
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Methane
Time Frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
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Changes in exhaled methane concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate.
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0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
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Hydrogen Area Under the Curve
Time Frame: -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
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Area Under the Curve (AUC) for exhaled hydrogen
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-2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
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Methane Area Under the Curve
Time Frame: -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
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Area Under the Curve (AUC) for exhaled methane
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-2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
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Fecal concentrations of SCFA
Time Frame: 0 and 6 weeks
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Changes in SCFA concentrations determined by a mixed model analysis
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0 and 6 weeks
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Determination and variations in fecal microbiota
Time Frame: 0 and 6 weeks
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Changes in microbiota determined by a mixed model analysis
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0 and 6 weeks
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Fecal concentrations of calprotectin
Time Frame: 0 and 6 weeks
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Changes in calprotectin concentrations determined by a mixed model analysis
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0 and 6 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic profile in 24h urine collections
Time Frame: 0 and 6 weeks
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Untargeted metabolic profile of urine samples measured in all samples collected 24 hours before the intervention with beta glucans as well as in samples collected 6 weeks later 24 hours before study termination.
The totality of the profiles is used to explore for changes after baseline as detected by multivariate statistics (PLS-DA)
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0 and 6 weeks
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Metabolic profile in 3d fecal collections
Time Frame: 0 and 6 weeks
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Untargeted metabolic profile of fecal samples measured in all samples collected 72-0 hours before the intervention with beta glucans as well as in samples collected 6 weeks later 72-0 hours before study termination.
The totality of the profiles is used to explore for changes after baseline as detected by multivariate statistics (PLS-DA)
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0 and 6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lars Ove Dragsted, PhD, University of Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M230
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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